Lipoic Acid for Chronic Inflammatory Demyelinating Polyneuropathy-A Randomized, Double-Blind, Placebo Controlled Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Muscle Strength
研究概览
简要总结
The purpose of the study is to examine if alpha lipoic acid is an effective treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).
详细描述
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a progressive disease leading to paralysis. CIDP is an immune-mediated disorder resulting from a synergistic interaction of T cell-mediated and B cell-mediated immune responses directed against peripheral nerve antigens. These immune mediated responses in turn increase the production of reactive oxygen intermediate and cause oxidative damage of the peripheral nerve system. Although corticosteroids, plasma exchange, and intravenous immunoglobulin (IVIg) reduce impairment caused by CIDP at least temporarily and can be used as a first-line treatments, they are not ideal for long-term treatment because of serious side effects and cost. Alpha lipoic acid (LA) is an antioxidant that also possesses anti-immune activity. It is effective in treating diabetic neuropathy. It is also promising in treating patients with multiple sclerosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of CIDP
- •on a stable dose of immunotherapy for at least 3 months before enrolling in the study
排除标准
- •myelopathy or evidence of central demyelination
- •persistent neurological deficits from stroke, CNS trauma, or peripheral neuropathy from other causes (eg, diabetes mellitus, IgM, paraproteinaemia, or uraemic, toxic, or familial neuropathy)
- •evidence of systemic disease that might cause neuropathy
- •heart diseases (congestive heart failure or arrhythmia)
- •pulmonary conditions (asthma or CIPD)
- •rheumatoid conditions (such as rheumatoid arthritis)
- •renal failure
研究组 & 干预措施
Lipoic acid
alpha lipoic acid
干预措施: lipoic acid (Drug)
Placebo
sugar pill
干预措施: lipoic acid (Drug)
结局指标
主要结局
Muscle Strength
时间窗: 16 weeks
次要结局
- Hughes Functional Disability Scale(16 weeks)
- Forced Vital Capacity (FVC)(16 weeks)
- Motor Nerve Conduction Studies (NCS)(16 weeks)
